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Impact of COL7A1 Gene Therapy on SCC Recurrence in RDEB Skin

RecruitingPhase 2Ages 18 Years - anyAllStanford University
NCT06731933 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The study objective is to see if BVEC induced C7 expression in Recessive Dystrophic Epidermolysis Bullosa (RDEB) skin following Squamous cell carcinoma (SCC) excision will normalize the invasive tumor microenvironment and reduce tumor recurrence. Prevention of SCC's in the RDEB subjects will increase their life span.

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Diagnosis of generalized Recessive dystrophic epidermolysis bullosa (RDEB) demonstrated by COL7A1 mutations 2. Presence of biopsy proven squamous cell carcinoma (SCC) 3. Ability to understand and the willingness to provide written informed consent. 4. US based participants are willing to use beremagene geperpavec (BVEC) 5. Subject is 18 years or older 6. participant willingness to use an effective method of contraception Exclusion Criteria: 1. Inability to travel to site for study visit 2. Subject is pregnant 3. Subject has Metastatic SCC's or is on any current systemic treatment for SCC.
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What it tests

  • BVEC
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Where

2 sites
Stanford University
Redwood City, United States
Azienda Ospedliero-Universitaia
Bari, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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